盐酸布替萘芬乳膏含量及有关物质的RP-HPLC测定

RP-HPLC determination of content and related substances in butenafine hydrochloride cream

目的:建立反相高效液相色谱法测定盐酸布替萘芬乳膏含量及有关物质。方法:采用 RP-HPLC 法,使用 Waters C_(18)柱(4.60 mm×150 mm,5μm),以甲醇-0.075%四甲基氢氧化铵水溶液(用磷酸调 pH 至6.8)(85:15)为流动相,流速为1.0 mL·min^(-1),在282 nm 波长处,测定盐酸布替萘芬乳膏的含量及有关物质。结果:该方法的线性范围为80.1～400.7μg·mL^(-1)(r=0.99997),平均回收率:99.47%(n=9),检出限2.5 ng。结论:该方法测定样品分离效果好,灵敏度高,重现性好,结果准确可靠。

Objective：To establish RP - HPLC method for determination of content and related substances in butenafine hydrochloride cream. Methods： An optimal RP - HPLC was set up. The samples were separated by Waters C18 column（4. 60 mm ×150mm,5 μm） with methanol-0. 075% tetra-n- methylammonium hydroxide solution（ adjust pH to 6.8 using phosphoric acid） （85：15 ）as mobile phase and detected with UV 282 nm and a flow rate of 1.0 mL · min^-1. Results ： The calibration curve was linear in the concentration range of 80. 1 - 400. 7 mL · min^-1（ r = 0. 99997 ） for the content determination ; The average recovery rate was 99. 47% （ n = 9 ）. The detection limit was 2. 5 ng. Conclusion：The method is good in the aspect of separable effect, reproducibility and sensitivity.